Health Canada is overseeing the market withdrawal of the antidepressant drug nefazodone

[Guest guest]

Still being given to the elderly in the US. Gotta love it.

http://www.hc-sc.gc.ca/english/protection/warnings/2003/2003_83.htm

2003-83

November 10, 2003

For immediate release

Advisory

OTTAWA -Health Canada is overseeing the market withdrawal of the

antidepressant drug called nefazodone. This action is in response to a Health

Canada safety evaluation that found nefazodone poses a risk of causing serious

liver-related adverse effects. This risk, while very remote, poses a greater

risk than other similar antidepressants currently available in Canada.

Nefazodone is a prescription-only product approved for sale in 1994 and

sold under the trade name SERZONE® by Bristol-Myers Squibb Canada Inc. The drug

is also sold under the following generic names: Lin-Nefazodone (Linson Pharma);

Apo-Nefazodone (Apotex Inc.); Nefazodone (Pharmel Inc.); Dom-Nefazodone

(Dominion Pharmacal); Novo-Nefazodone-5HT2 (Novopharm Limited); PMS-Nefazodone

(Pharmascience Inc.); and Gen-Nefazodone (Genpharm Inc.).

Health Canada is aware of at least 38 reported cases in Canada of

liver-related adverse effects, including one death, suspected to be associated

with nefazodone products between 1994 and the end of last year. Earlier this

year, Health Canada requested that manufacturers of nefazodone products submit

the latest scientific information available to support the safety of the drug.

Health Canada evaluated this data, along with the latest information from the

scientific literature, and concluded that, given there are other similar

antidepressants available that pose less of a risk, the sale of nefazodone in

Canada should be stopped.

Bristol-Myers Squibb and Linson Pharma have agreed to have their

nefazodone products withdrawn by November 27, 2003. Health Canada is working

with other manufacturers of nefazodone to ensure the products are withdrawn from

the Canadian market in a timely manner. A transition period has been established

to allow time for patients taking nefazodone products to consult with their

health care professionals about appropriate alternative treatments. This time is

important for patients due to the risks associated with patients who abruptly

stop taking their antidepressant medication.

Health Canada advises patients on nefazodone to consult with their health

care professional as soon as possible to make arrangements for alternative

therapies. Health Canada also advises patients to contact their health care

professionals if they have experienced any of the following adverse effects from

taking products containing nefazodone:

a.. jaundice (yellowing of the skin or whites of the eyes)

b.. brown urine

c.. nausea

d.. vomiting

e.. unusual tiredness

f.. weakness

g.. stomach or abdominal pain

h.. loss of appetite

Health Canada issued an advisory regarding nefazodone in July, 2001, to

inform Canadians about the latest information available at that time. Health

Canada also oversaw the issuance of a letter from the manufacturers of

nefazodone to health care professionals in June, 2001, and published two

articles in the Canadian Adverse Reaction Newsletter, one in 1999 and the other

this year, to keep the medical community informed about the drug. These

documents are available on the Health Canada web site at the addresses listed

below.

Nefazodone has been available internationally since 1993. Earlier this

year, Bristol-Myers Squibb removed SERZONE® from the market in Europe, while

Spain and Turkey both suspended its sale. While nefazodone is still sold in the

U.S., the FDA in 2002 required Bristol-Myers Squibb to issue a letter to health

care professionals advising them of the latest risk information about the drug

and informing them of changes made to the drug's prescribing information.

Health Canada is asking consumers and health care professionals to report

any suspected adverse effects associated with the use of nefazodone products to

Health Canada using the following contact information:

Toll free phone: 1-866-234-2345

Toll free fax: 1-866-678-6789

E-mail: cadrmp@...

Mail:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0201C2

OTTAWA, Ontario, K1A 1B9

a.. Nefazodone Advisory, July 2001

b.. Bristol-Myers Squibb and Linson Pharma Inc. letter to health care

professionals, June 20 2001

c.. Apotex Inc. letter to health care professionals, June 28, 2001

d.. Canadian Adverse Reaction Newsletter, July 1999

e.. Canadian Adverse Reaction Newsletter, January 2003

-30-

--------------------------------------------------------------------------

Media Inquiries:

Krista Apse

Health Canada

(613) 941-8189

Public Inquiries:

(613) 957-2991

Last Updated: 2003-11-10

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

[Guest guest]

Still being given to the elderly in the US. Gotta love it.

http://www.hc-sc.gc.ca/english/protection/warnings/2003/2003_83.htm

2003-83

November 10, 2003

For immediate release

Advisory

OTTAWA -Health Canada is overseeing the market withdrawal of the

antidepressant drug called nefazodone. This action is in response to a Health

Canada safety evaluation that found nefazodone poses a risk of causing serious

liver-related adverse effects. This risk, while very remote, poses a greater

risk than other similar antidepressants currently available in Canada.

Nefazodone is a prescription-only product approved for sale in 1994 and

sold under the trade name SERZONE® by Bristol-Myers Squibb Canada Inc. The drug

is also sold under the following generic names: Lin-Nefazodone (Linson Pharma);

Apo-Nefazodone (Apotex Inc.); Nefazodone (Pharmel Inc.); Dom-Nefazodone

(Dominion Pharmacal); Novo-Nefazodone-5HT2 (Novopharm Limited); PMS-Nefazodone

(Pharmascience Inc.); and Gen-Nefazodone (Genpharm Inc.).

Health Canada is aware of at least 38 reported cases in Canada of

liver-related adverse effects, including one death, suspected to be associated

with nefazodone products between 1994 and the end of last year. Earlier this

year, Health Canada requested that manufacturers of nefazodone products submit

the latest scientific information available to support the safety of the drug.

Health Canada evaluated this data, along with the latest information from the

scientific literature, and concluded that, given there are other similar

antidepressants available that pose less of a risk, the sale of nefazodone in

Canada should be stopped.

Bristol-Myers Squibb and Linson Pharma have agreed to have their

nefazodone products withdrawn by November 27, 2003. Health Canada is working

with other manufacturers of nefazodone to ensure the products are withdrawn from

the Canadian market in a timely manner. A transition period has been established

to allow time for patients taking nefazodone products to consult with their

health care professionals about appropriate alternative treatments. This time is

important for patients due to the risks associated with patients who abruptly

stop taking their antidepressant medication.

Health Canada advises patients on nefazodone to consult with their health

care professional as soon as possible to make arrangements for alternative

therapies. Health Canada also advises patients to contact their health care

professionals if they have experienced any of the following adverse effects from

taking products containing nefazodone:

a.. jaundice (yellowing of the skin or whites of the eyes)

b.. brown urine

c.. nausea

d.. vomiting

e.. unusual tiredness

f.. weakness

g.. stomach or abdominal pain

h.. loss of appetite

Health Canada issued an advisory regarding nefazodone in July, 2001, to

inform Canadians about the latest information available at that time. Health

Canada also oversaw the issuance of a letter from the manufacturers of

nefazodone to health care professionals in June, 2001, and published two

articles in the Canadian Adverse Reaction Newsletter, one in 1999 and the other

this year, to keep the medical community informed about the drug. These

documents are available on the Health Canada web site at the addresses listed

below.

Nefazodone has been available internationally since 1993. Earlier this

year, Bristol-Myers Squibb removed SERZONE® from the market in Europe, while

Spain and Turkey both suspended its sale. While nefazodone is still sold in the

U.S., the FDA in 2002 required Bristol-Myers Squibb to issue a letter to health

care professionals advising them of the latest risk information about the drug

and informing them of changes made to the drug's prescribing information.

Health Canada is asking consumers and health care professionals to report

any suspected adverse effects associated with the use of nefazodone products to

Health Canada using the following contact information:

Toll free phone: 1-866-234-2345

Toll free fax: 1-866-678-6789

E-mail: cadrmp@...

Mail:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0201C2

OTTAWA, Ontario, K1A 1B9

a.. Nefazodone Advisory, July 2001

b.. Bristol-Myers Squibb and Linson Pharma Inc. letter to health care

professionals, June 20 2001

c.. Apotex Inc. letter to health care professionals, June 28, 2001

d.. Canadian Adverse Reaction Newsletter, July 1999

e.. Canadian Adverse Reaction Newsletter, January 2003

-30-

--------------------------------------------------------------------------

Media Inquiries:

Krista Apse

Health Canada

(613) 941-8189

Public Inquiries:

(613) 957-2991

Last Updated: 2003-11-10

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

[Guest guest]

Still being given to the elderly in the US. Gotta love it.

http://www.hc-sc.gc.ca/english/protection/warnings/2003/2003_83.htm

2003-83

November 10, 2003

For immediate release

Advisory

OTTAWA -Health Canada is overseeing the market withdrawal of the

antidepressant drug called nefazodone. This action is in response to a Health

Canada safety evaluation that found nefazodone poses a risk of causing serious

liver-related adverse effects. This risk, while very remote, poses a greater

risk than other similar antidepressants currently available in Canada.

Nefazodone is a prescription-only product approved for sale in 1994 and

sold under the trade name SERZONE® by Bristol-Myers Squibb Canada Inc. The drug

is also sold under the following generic names: Lin-Nefazodone (Linson Pharma);

Apo-Nefazodone (Apotex Inc.); Nefazodone (Pharmel Inc.); Dom-Nefazodone

(Dominion Pharmacal); Novo-Nefazodone-5HT2 (Novopharm Limited); PMS-Nefazodone

(Pharmascience Inc.); and Gen-Nefazodone (Genpharm Inc.).

Health Canada is aware of at least 38 reported cases in Canada of

liver-related adverse effects, including one death, suspected to be associated

with nefazodone products between 1994 and the end of last year. Earlier this

year, Health Canada requested that manufacturers of nefazodone products submit

the latest scientific information available to support the safety of the drug.

Health Canada evaluated this data, along with the latest information from the

scientific literature, and concluded that, given there are other similar

antidepressants available that pose less of a risk, the sale of nefazodone in

Canada should be stopped.

Bristol-Myers Squibb and Linson Pharma have agreed to have their

nefazodone products withdrawn by November 27, 2003. Health Canada is working

with other manufacturers of nefazodone to ensure the products are withdrawn from

the Canadian market in a timely manner. A transition period has been established

to allow time for patients taking nefazodone products to consult with their

health care professionals about appropriate alternative treatments. This time is

important for patients due to the risks associated with patients who abruptly

stop taking their antidepressant medication.

Health Canada advises patients on nefazodone to consult with their health

care professional as soon as possible to make arrangements for alternative

therapies. Health Canada also advises patients to contact their health care

professionals if they have experienced any of the following adverse effects from

taking products containing nefazodone:

a.. jaundice (yellowing of the skin or whites of the eyes)

b.. brown urine

c.. nausea

d.. vomiting

e.. unusual tiredness

f.. weakness

g.. stomach or abdominal pain

h.. loss of appetite

Health Canada issued an advisory regarding nefazodone in July, 2001, to

inform Canadians about the latest information available at that time. Health

Canada also oversaw the issuance of a letter from the manufacturers of

nefazodone to health care professionals in June, 2001, and published two

articles in the Canadian Adverse Reaction Newsletter, one in 1999 and the other

this year, to keep the medical community informed about the drug. These

documents are available on the Health Canada web site at the addresses listed

below.

Nefazodone has been available internationally since 1993. Earlier this

year, Bristol-Myers Squibb removed SERZONE® from the market in Europe, while

Spain and Turkey both suspended its sale. While nefazodone is still sold in the

U.S., the FDA in 2002 required Bristol-Myers Squibb to issue a letter to health

care professionals advising them of the latest risk information about the drug

and informing them of changes made to the drug's prescribing information.

Health Canada is asking consumers and health care professionals to report

any suspected adverse effects associated with the use of nefazodone products to

Health Canada using the following contact information:

Toll free phone: 1-866-234-2345

Toll free fax: 1-866-678-6789

E-mail: cadrmp@...

Mail:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0201C2

OTTAWA, Ontario, K1A 1B9

a.. Nefazodone Advisory, July 2001

b.. Bristol-Myers Squibb and Linson Pharma Inc. letter to health care

professionals, June 20 2001

c.. Apotex Inc. letter to health care professionals, June 28, 2001

d.. Canadian Adverse Reaction Newsletter, July 1999

e.. Canadian Adverse Reaction Newsletter, January 2003

-30-

--------------------------------------------------------------------------

Media Inquiries:

Krista Apse

Health Canada

(613) 941-8189

Public Inquiries:

(613) 957-2991

Last Updated: 2003-11-10

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

[Guest guest]

Still being given to the elderly in the US. Gotta love it.

http://www.hc-sc.gc.ca/english/protection/warnings/2003/2003_83.htm

2003-83

November 10, 2003

For immediate release

Advisory

OTTAWA -Health Canada is overseeing the market withdrawal of the

antidepressant drug called nefazodone. This action is in response to a Health

Canada safety evaluation that found nefazodone poses a risk of causing serious

liver-related adverse effects. This risk, while very remote, poses a greater

risk than other similar antidepressants currently available in Canada.

Nefazodone is a prescription-only product approved for sale in 1994 and

sold under the trade name SERZONE® by Bristol-Myers Squibb Canada Inc. The drug

is also sold under the following generic names: Lin-Nefazodone (Linson Pharma);

Apo-Nefazodone (Apotex Inc.); Nefazodone (Pharmel Inc.); Dom-Nefazodone

(Dominion Pharmacal); Novo-Nefazodone-5HT2 (Novopharm Limited); PMS-Nefazodone

(Pharmascience Inc.); and Gen-Nefazodone (Genpharm Inc.).

Health Canada is aware of at least 38 reported cases in Canada of

liver-related adverse effects, including one death, suspected to be associated

with nefazodone products between 1994 and the end of last year. Earlier this

year, Health Canada requested that manufacturers of nefazodone products submit

the latest scientific information available to support the safety of the drug.

Health Canada evaluated this data, along with the latest information from the

scientific literature, and concluded that, given there are other similar

antidepressants available that pose less of a risk, the sale of nefazodone in

Canada should be stopped.

Bristol-Myers Squibb and Linson Pharma have agreed to have their

nefazodone products withdrawn by November 27, 2003. Health Canada is working

with other manufacturers of nefazodone to ensure the products are withdrawn from

the Canadian market in a timely manner. A transition period has been established

to allow time for patients taking nefazodone products to consult with their

health care professionals about appropriate alternative treatments. This time is

important for patients due to the risks associated with patients who abruptly

stop taking their antidepressant medication.

Health Canada advises patients on nefazodone to consult with their health

care professional as soon as possible to make arrangements for alternative

therapies. Health Canada also advises patients to contact their health care

professionals if they have experienced any of the following adverse effects from

taking products containing nefazodone:

a.. jaundice (yellowing of the skin or whites of the eyes)

b.. brown urine

c.. nausea

d.. vomiting

e.. unusual tiredness

f.. weakness

g.. stomach or abdominal pain

h.. loss of appetite

Health Canada issued an advisory regarding nefazodone in July, 2001, to

inform Canadians about the latest information available at that time. Health

Canada also oversaw the issuance of a letter from the manufacturers of

nefazodone to health care professionals in June, 2001, and published two

articles in the Canadian Adverse Reaction Newsletter, one in 1999 and the other

this year, to keep the medical community informed about the drug. These

documents are available on the Health Canada web site at the addresses listed

below.

Nefazodone has been available internationally since 1993. Earlier this

year, Bristol-Myers Squibb removed SERZONE® from the market in Europe, while

Spain and Turkey both suspended its sale. While nefazodone is still sold in the

U.S., the FDA in 2002 required Bristol-Myers Squibb to issue a letter to health

care professionals advising them of the latest risk information about the drug

and informing them of changes made to the drug's prescribing information.

Health Canada is asking consumers and health care professionals to report

any suspected adverse effects associated with the use of nefazodone products to

Health Canada using the following contact information:

Toll free phone: 1-866-234-2345

Toll free fax: 1-866-678-6789

E-mail: cadrmp@...

Mail:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0201C2

OTTAWA, Ontario, K1A 1B9

a.. Nefazodone Advisory, July 2001

b.. Bristol-Myers Squibb and Linson Pharma Inc. letter to health care

professionals, June 20 2001

c.. Apotex Inc. letter to health care professionals, June 28, 2001

d.. Canadian Adverse Reaction Newsletter, July 1999

e.. Canadian Adverse Reaction Newsletter, January 2003

-30-

--------------------------------------------------------------------------

Media Inquiries:

Krista Apse

Health Canada

(613) 941-8189

Public Inquiries:

(613) 957-2991

Last Updated: 2003-11-10

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss